DATA USE AGREEMENT

This Data Use Agreement for Limited Data Sets (the “Agreement”) is made this _____ day of ______, 200_ (“Effective Date”) by and between ______

______(“Covered Entity”) and ______, the principal investigator (referred to herein as “Recipient”).

WHEREAS, 45 CFR 164, Subpart E (titled “Standards for Privacy of Individually Identifiable Health Information” and herein referred to as the “HIPAA Privacy Regulations”) allows Covered Entity to make available for the purposes of research, public health or health care operations a limited data set to Recipient, provided that Recipient agrees to be bound by the terms of this Agreement; and

WHEREAS, Recipient desires for Covered Entity to make available the limited data set described below and agrees to be bound by the terms and conditions of this Agreement; and

WHEREAS, Covered Entity agrees to make available said limited data set, provided that Recipient agrees to abide by the terms and conditions of this Agreement as well as applicable federal and Indiana state laws, Covered Entity’s policies, and any applicable Purdue University IRB requirements.

NOW, THEREFORE, in consideration of the mutual covenants and promises hereinafter set forth, the parties hereto agree as follows:

1.DEFINITIONS

For the purposes of this Agreement, terms used herein shall have the same definitions as those set forth in the HIPAA Privacy Regulations.

2.LIMITED DATA SET TO BE PROVIDED BY COVERED ENTITY

  1. The limited data set provided pursuant to this Agreement contains data obtained or created by Covered Entity and related to [identify the specific nature of the data and the specific data elements being requested.]

______

______

______

The data to be disclosed shall be limited to data that is the minimum necessary to reasonably accomplish the Authorized Purposes identified in Section (3)(a) of this Agreement.

b.Consistent with the HIPAA Privacy Regulations the limited data set shall not include any of the following identifiers:

1)Names

2)Postal address information (other than town or city, state and zip code)

3)Telephone numbers

4)Fax numbers

5)E-mail addresses

6)Social security numbers

7)Medical record numbers

8)Health plan beneficiary numbers

9)Account numbers

10)Certificate/license numbers

11)Vehicle identifiers & serial numbers, including license plate numbers

12)Device identifiers & serial numbers

13)Web Universal Resource Locators (URL’s)

14)Internet Protocol (IP) address numbers

15)Biometric identifiers, including finger and voice prints

16)Full face photographic images and any comparable images

  1. PERMITTED USES AND DISCLOSURES
  1. Recipient agrees to limit the use and disclosure of the limited data set to conduct the research described below (“Authorized Purposes”): [specify the generalpurpose(s) for the limited data set.]

______

______

  1. The Recipient shall allow only those members of its workforce who have a legitimate business need for the data to access the limited data set.
  1. ADDITIONAL ASSURANCES BY RECIPIENT
  1. Recipient shall not use or further disclose the limited data set other than as permitted by this Agreement or as otherwise required by law.
  1. Recipient shall use appropriate safeguards to prevent use or disclosure of the limited data set other than as permitted by this Agreement.
  1. Recipient shall report to the Covered Entity’s Privacy Officer any use or disclosure of the limited data set not provided for by this Agreement of which Recipient becomes aware.
  1. Recipient shall ensure that any agents, including a subcontractor to whom it provides the limited data set, agree to the same restrictions and conditions that apply to the Recipient with respect to such information.
  1. Recipient shall not re-identify the information or contact the individuals whose information is contained within the limited data set.
  1. BREACH AND TERMINATION
  1. In the event that Recipient breaches this Agreement, Covered Entity, at its sole discretion, may: i) terminate this Agreement upon written notice to Recipient, or ii) request that Recipient, to the satisfaction of Covered Entity, take appropriate steps to cure such breach. If Recipient fails to cure such breach to Covered Entity's satisfaction or in the time prescribed by Covered Entity, Covered Entity may terminate this Agreement upon written notice to Recipient.
  2. Should this Agreement be terminated for any reason, including, but not limited to Recipient’s decision to cease use of the limited data set data, Recipient agrees to destroy or return all limited data set data provided pursuant to this Agreement (including copies or derivative versions thereof).
  1. MISCELLANEOUS
  1. Notices. Any notice permitted or required as provided for herein shall be in writing and to the contact and address as noted below or as may be provided by either party to the other in writing from time to time.

Notice to Covered Entity shall be to:

Director HIPAA Privacy Office

PurdueUniversityStudentHealthCenter

601 Stadium Mall Drive

West Lafayette, IN47907-2052

Notice to Recipient shall be to:

______

______

______

  1. Governing Law. This Agreement shall be governed by, and construed in accordance with, the laws of the State of Indiana, without regard to its choice of law rules.
  1. No Third Party Beneficiaries. There are no third party beneficiaries to this Agreement. Nothing contained in this Agreement shall be construed to create any contractual or other rights on behalf of any individual whose protected health information is used or disclosed under this Agreement.
  1. Survival. The rights and obligations of Recipient set forth in Sections 3, 4 and 5 shall survive the termination of this Agreement

IN WITNESS WHEREOF, the Parties have executed this Agreement effective upon the Effective Date set forth above.

COVERED ENTITYRECIPIENT (Principal Investigator)

Name (print): ______Name (print): ______

Title: ______Title: ______

Signature: ______Signature: ______

(If covered entity providing the data is outside Purdue and Principal Investigator is a Purdue researcher, obtain the following signature in addition to above)

Name (print): ______

Title: Purdue SPS Contract Analyst___

Signature: ______

Cc: Purdue University IRB

1

312954.1

Revised July 9, 2008